Senior Clinical Research Associate (Contractor)

at  Premier Research

Premier Research is looking for a Freelance / Contract Senior CRA with recent experience in Oncology and ideally experience also in medical devices and rare disease studies, to join our Clinical Monitoring team with a start date of early September 2024 start date and a contract duration of 6 months.
Ideally located in Milan, we can consider either a 0.8 or full FTE. The successful freelancer will perform, on average 4-7 site monitoring visits across Italy.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
We are Built by You. Your ideas influence the way we work, and your voice matters here.
We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.

• Conducting Monitoring visits such as (Qualification, SIV, RMV and COVs)
• Site management
• Supporting upcoming database lock
• Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
• Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines.
• Reviews site documents and verifies they are accurate, complete, current, and include required updates.
• Maintain communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts.